Saving Brain in Uganda and Burkina Faso
Saving Brains In Uganda And Burkina Faso (PROMISE Saving Brains)
調査の概要
状態
詳細な説明
Between 2006 and 2008 we carried out a cluster randomized study (PROMISE-EBF) to establish the effect of individual home based peer counselling on exclusive breast feeding (EBF). The results, published in the Lancet in 2011 were remarkable(Tylleskar T, et al). The PROMISE-EBF trial which compared mothers in the intervention arm that were offered at least 5 peer-visits promoting EBF to mothers in the control arm, that received the standard of care showed a doubling in the prevalence of EBF in the intervention arm. Community-based peer counsellors increased the EBF rate in Uganda and Burkina Faso from about 40% to 80%.
The current study will trace and re-enrol at least 70% of the children involved in the PROMISE-EBF study. These children are now aged between 5 and 7 years.
The primary objective of the current study is to evaluate the effect of peer-counselling for EBF in the first six months of life on human capital formation among children in Uganda and Burkina Faso.
This study will contribute to a crucial wider discussion on external validity regarding the relationship between EBF and intellectual performance and mental health. In the social area, this study will identify solutions to potential barriers that limit scale up for peer-counselling for EBF. From the business perspective, the study will identify the best business model for affordable, acceptable and cost effective ways of delivering peer counselling for EBF in Burkina Faso and Uganda. If this intervention is found effective, and is adopted, it could improve productivity in adulthood and work towards breaking the cycle of poverty.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Kampala、ウガンダ
- Makerere University
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Children whose mothers participated in the original intervention of peer support for exclusive breastfeeding (EBF).
- Informed caregiver consent
Exclusion Criteria:
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:ヘルスサービス研究
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Behavioral
Peer support for mothers to encourage them to exclusively breastfeed their babies for 6 months
|
Pregnant women were identified and randomized to peer support for exclusive breastfeeding in clusters.
They were followed up for 6 months post delivery.
他の名前:
|
|
介入なし:Control
No peer support for exclusive breastfeeding
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Cognitive function
時間枠:one year
|
Proportion of children with impaired cognitive function in intervention compared to the control group
|
one year
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Cost-effectiveness of promoting peer-counselling for exclusive breastfeeding in the first six months of life to support human capital formation
時間枠:3 months
|
Determine the cost of promoting peer counselling for exclusive breastfeeding in relation to the cost of attending to children with poor outcomes
|
3 months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
School attainment
時間枠:One year
|
School attainment in the intervention compared to school attainment in the control group
|
One year
|
|
School readiness
時間枠:One year
|
The age at which children are ready to start school in the intervention compared to the control group.
|
One year
|
|
Physical growth
時間枠:One year
|
Compare the proportion of children with poor nutritional status in the intervention and control group.
|
One year
|
|
Behavioural and emotional status
時間枠:One year
|
Behavioral and emotional status of children in the intervention compared to those in the control group
|
One year
|
|
Household economic status
時間枠:One year
|
Assess the social economic status in the intervention compared to the social economic status in the control group.
|
One year
|
|
Motor skills
時間枠:One year
|
Compare motor skills of children in the intervention compared to the control group using MABC
|
One year
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:James K Tumwine, PhD、Makerere University
出版物と役立つリンク
一般刊行物
- Engebretsen IMS, Nalugya JS, Skylstad V, Ndeezi G, Akol A, Babirye JN, Nankabirwa V, Tumwine JK. "I feel good when I drink"-detecting childhood-onset alcohol abuse and dependence in a Ugandan community trial cohort. Child Adolesc Psychiatry Ment Health. 2020 Oct 24;14:42. doi: 10.1186/s13034-020-00349-z. eCollection 2020.
- Tumwine JK, Nankabirwa V, Diallo HA, Engebretsen IMS, Ndeezi G, Bangirana P, Sanou AS, Kashala-Abotnes E, Boivin M, Giordani B, Elgen IB, Holding P, Kakooza-Mwesige A, Skylstad V, Nalugya J, Tylleskar T, Meda N. Exclusive breastfeeding promotion and neuropsychological outcomes in 5-8 year old children from Uganda and Burkina Faso: Results from the PROMISE EBF cluster randomized trial. PLoS One. 2018 Feb 23;13(2):e0191001. doi: 10.1371/journal.pone.0191001. eCollection 2018.
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。